# K121926: Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with Protein Labling Claim (50UG/DM

- Pathway: 510(k) (Traditional)
- Applicant: Northstar Healthcare Holdings
- Decided: Sep 20, 2012 after 80 days
- Product code: LZC (Medical Glove, Specialty)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972615 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083409: Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label, Wrp Asia Pacific Sdn. Bhd. (2009) Summary page 1.

## Most influential descendants
- K221157: JR Medic (2022), 0 descendants of its own

## Indications for use
The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (BCNU)(3.3 mg/mL) 15.4 Cisplatin (1.0 mg/mL) >240 Cyclophosphamide (Cytoxan) (20.0 mg/mL) >240 Dacarbazine (DTIC) (10.0 mg/mL) >240 Doxorubicin Hydrochloride (2.0 mg/mL) >240 Etoposide (20.0 mg/mL) >240 Fluorouracil (Adrucil) (50.0 mg/mL) >240 Methotrexate (25 mg/mL) >240 Mitomycin C (0.5mg/mL) >240 Paclitaxel (taxol) (6.0 mg/mL) >240 Thiotepa (10.0 mg/mL) 1.6 Vincristine Sulfate (1.0 mg/mL) >240 The maximum testing time is 240 minutes- Please note that the following drugs, Carmustine (BCNUJ) and Thiotepa have extremely low permeation time of less than 30 minutes.

Source page: https://510kreport.com/device/K121926
Methodology: https://510kreport.com/methodology